Biofeedback electronic stimulation device

ABSTRACT

A biofeedback electronic stimulation device includes a processor for generating a first control signal and a plurality of second control signals responsive to at least one input signal. Transformer circuitry generates a stimulation signal including packets of at least one pulse responsive to the first control signal. Pulse circuitry configures the at least one pulse in the packet to a selected one of a plurality of configurations responsive to the plurality of second control signals. Output electrodes apply the at least one pulse in the packet to a user and detector circuitry detects zero crossings of the at least one pulse in the packet. The processor further causes generation of an indicator responsive to the detected zero crossings.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Divisional of U.S. patent application Ser. No.11/203,387, filed on Aug. 12, 2005, which claims priority to U.S.Provisional Patent Application Ser. No. 60/601,075, filed on Aug. 12,2004 and entitled “BIOFEEDBACK ELECTRONIC STIMULATION DEVICE,” which isincorporated herein by reference.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to pain management systems, and moreparticularly, to biofeedback electronic stimulation devices.

BACKGROUND OF THE INVENTION

There are many people with injuries and ailments that may be treated byelectrical energy. Examples include sprained ankles, carpal tunnelsyndrome, arthritis, and numbness of extremities like neuropathy, strokeand neurological conditions such as ADD and macular degeneration. Theseare all ailments that the human body must work to recover from. They arenot viruses or infections or any chemically related ailment. These arenot instances where surgery has proven effective, such as reattachingbones or ligaments or other body parts or clearing arteries.

Energetic medicine addresses these energy related ailments. There hasbeen much research into energetic medicine and the way the body'selectric and nervous system works dating back to the 1900s. Devices havebeen developed, such as the Rife machine, Beck's Box, infrared lighttherapies, and magnetic therapies used in energetic medicine. There arediagnostic tools such as MEAD machines, which measure resistance in thebody's energetic pathways called energy meridians. There are alsotreatment machines in the category in TENS and electronic acupuncture.With respect to the use of machinery based upon TENS strategy, most ofthese devices utilize electronic stimulation to mask the pain of a userrather than to physically assist the body to recover from a particularinjury. Thus, there is a need for devices that actively assist the bodyin healing from particular types of injuries using electrical energy.

SUMMARY OF THE INVENTION

The present invention disclosed and claimed herein, in one aspectthereof, comprises a biofeedback electronic stimulation device. Thedevice has a user interface enabling a user to select at least one inputsignal. A processor within the device generates a first control signaland a plurality of second control signals responsive to the at least oneinput signal. Transformer circuitry generates a stimulation signalincluding packets containing at least one pulse responsive to the firstcontrol signal from the processor. Pulse circuitry configures at leastone pulse in the packet to a selected one of a plurality ofconfigurations responsive to the plurality of second control signals.The stimulation signal is applied to the body of a user using outputelectrodes. Detector circuitry detects zero crossings of the at leastone pulse in the packet of the stimulation signal, and the processorgenerates an indicator responsive to the detected zero crossings.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention and theadvantages thereof, reference is now made to the following descriptiontaken in conjunction with the accompanying Drawings in which:

FIG. 1 is a block diagram of the biofeedback electronic stimulationdevice of the present invention;

FIG. 2 is a schematic diagram of the transformer circuit and associatedtransformer shunt;

FIG. 2 a is a schematic diagram of the level translator circuitry;

FIG. 3 a-3 b is a schematic diagram of the microcontroller of thedevice;

FIG. 4 is a schematic diagram of the detector circuit of the device;

FIG. 5 is a flow diagram illustrating the manner in which the controlprocessor operates within the device to provide control signals;

FIG. 6 is a flow diagram illustrating the feedback control loop of thebiofeedback electronic stimulation device;

FIG. 7 illustrates the stimulation signal generated by the biofeedbackelectronic stimulation device, and the various manners in which thepackets and pulses may be controlled; and

FIGS. 8 a-8 d illustrate various output signals of the biofeedbackelectronic stimulation device.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, wherein like reference numbers are usedherein to designate like elements throughout the various views,embodiments of the present invention are illustrated and described, andother possible embodiments of the present invention are described. Thefigures are not necessarily drawn to scale, and in some instances thedrawings have been exaggerated and/or simplified in places forillustrative purposes only. One of ordinary skill in the art willappreciate the many possible applications and variations of the presentinvention based on the following examples of possible embodiments of thepresent invention.

Referring now to FIG. 1, there is illustrated a block diagram of thebiofeedback electronic stimulation device of the present invention. Thedevice includes a circuit board 102 for containing each of theelectronic components. The controlling portion of the device consists ofa microprocessor 104. The microprocessor 104 contains a set of storedinstructions for controlling the operation of the biofeedback device.The microprocessor 104 in conjunction with other components of thedevice which will be discussed herein below generate output pulsepackets for application to an individual's body. The microprocessor 104is interconnected with a number of components on the circuit board 102from which the microprocessor 104 receives inputs from and providesoutputs to. An on/off switch 106 provides the user with the ability toturn the entire biofeedback electronic stimulation device on and off.The on/off switch 106 may comprise a standard push button switch or aconventional two position switch in order to place the device in poweredand non-powered states. A connector jack 108 enables external probes tobe connected to the biofeedback electronic stimulation device. Thedevice also includes a USB port 110 to enable universal serial busconnections to the microprocessor 104. Through the USB connection 110, aUSB communications cable may be connected to enable USB communicationsbetween the microprocessor 104 and an external device.

A pair of electrodes 112 provide a stimulation signal from the outputcircuitry 114 and provide a connection point between the biofeedbackelectronic stimulation device and a body of a user. The outputelectrodes 112 connect the device to a point on a body of a user. Thepair of electrodes 112 additionally provide an input for measuring abody's response to the applied electric signals through the electrodes112. A connector 116 enables a battery 118 to be interconnected to thebiofeedback electronic stimulation device to power the microcontroller104 and associated circuitry. The power level selector 120 enables auser to adjust the power level applied to a transformer 122 within theoutput circuitry 114 by the microprocessor 104 to various levels. Theapplied power level alters the strength of the stimulation signal outputfrom electrodes 112 to a user's body.

Treatment selector switch 124 selects the particular mode of operationfor the biofeedback electronic stimulation device. The selectedtreatment mode from switch 124 provides an indication to themicroprocessor 104 of a particular operating mode. The microprocessor104 configures the pulse generator circuitry 126 to provide a desiredpulse output according to the selected mode of operation. A series ofdisplay LEDs and/or LCDs 128 provide a visual indication of the powerlevel of the device, the mode of operation or other device status.Additionally, a speaker 130 may be used to provide audible indicators toa user of various operating conditions. Various visual and audibleindications are provided by the LEDs and LCDs 128 or the speaker 130.These instructions include a mode indication, a power level indication,a battery power indication, a sensor connection indication, a bodyresponse status, a time status, body measurement readings, USB interfacestatus, instructional information, treatment status, or diagnosisinformation. The transformer circuit 122 is energized by signals from apulse generator circuit 126.

The output circuitry 114 is connected to and controlled by themicroprocessor 104 to generate output pulses in a stimulation signalthrough the electrodes 112. The output circuitry 114 also receivesfeedback signals from the electrodes 112 to control the operation of themicroprocessor 104. A transformer 122 generates a signal includingpackets of one or more pulses responsive to removal of an appliedcurrent from the transformer 122 controlled by the microprocessor 104.The transformer circuit 122 is energized by signals from a pulsegenerator circuit 126. The output pulses provided from the transformermay be clamped by damping circuitry 125. The various characteristics ofthe pulse generated by the pulse generator 126 are controlled responsiveto control inputs from the microprocessor 104. A detector circuit 132 isresponsible for detecting the zero crossing of the pulse signalsprovided at the electrodes 112. The time between the zero crossing isused by the microprocessor 104 to determine when the device may beremoved from the body. The sensor circuit 134 provides the measurementsfor the zero crossings.

Referring now to FIG. 2, there is illustrated a schematic diagram of thetransformer circuitry 122 the pulse generator circuitry 126 and thedamping circuitry 125. A charging current is applied at input 202 toresistor 204. The charging current is provided from the level translatorcircuit 270 (FIG. 2 a) under control of the microprocessor 104. Thecharging current provides energy to a transformer 206 for generating thestimulation signal. Resistor 204 is also connected to node 208. An anodeof diode 210 is connected to node 208 and the cathode of diode 210 isconnected to VBatt. A resistor 212 is connected between VBatt and node208. The base of transistor 214 is connected to node 208 and theemitter-collector path of transistor 214 is connected between node 216and node 218. A diode 220 has its anode connected to VBatt and itscathode connected to node 216. A diode 222 has its anode connected tonode 218 and its cathode connected to a center tap 224 of transformer206. One side of transformer 206 is connected to ground, and theopposite side of transformer 206 is connected to node 226. When acharging current is applied to node 202, transistor 214 is turned oncausing a current to be applied to the center tap 224 of transformer 206by the pulse generator circuitry 126 and begin energizing thetransformer.

A resistor 228 is connected between node 226 and node 230. In thepreferred embodiment, the resistor 228 has a value of 150 kilo ohms. Acapacitor 232 is in parallel with resistor 228 between nodes 226 and230. In a preferred embodiment, the capacitor 232 has a value of 500picofarads. This capacitor can eliminate the need for the damping device246 discussed below by limiting the amplitude of pulses generated by thetransformer 206. A resistor 234 is connected between node 230 andground. Sensor one output 236 is connected to node 226. Sensor twooutput 238 is connected to node 230. An external sensor 240 is connectedbetween node 226 and node 230. The transformer circuitry 122 isinterconnected with the damping circuitry 125 via a capacitor 242. Thecapacitor 242 is located between the center tap 224 and node 244 of thedamping circuitry 125.

The damping circuitry 125 includes a clamping device 246 located betweennode 244 and node 226. The clamping device 246 prevents the pulsesgenerated when the current is released from the transformer 206 fromexceeding a particular amplitude. In a preferred embodiment, theclamping device 246 comprises a bidirectional rectifying diode. Theremaining portion of the pulse generator circuitry 126 consists of atransformer shunt enabling the load applied across the transformer 206to be adjusted by switching resistances into and out of the load appliedto the transformer 206. The transformer shunt consists of three relays250, which switch a resistor load 254 into and out of the circuit. Eachrelay 250 has four connections. A first connection is connected to aresistor 252 that is also connected to the system voltage. The relays250 have a second connection to a load resistor 254 connected betweenthe relay and node 226. Another connection of the relay 250 is connectedto control inputs 256 from the microprocessor 104. A light emittingdiode 258 is connected between the connection to resistor 252 and theinput connected to the control input 256. The light emitting diode 258,when lit actuates a pair of photo sensitive transistors 260 connectedbetween third and fourth inputs of the relay 250. When a control signalis applied to input 256 of one of the relays 250, the light emittingdiode 258 causes the actuation of the photo sensitive transistor pair260, which switches the resistor 254 of the transformer shunt across thetransformer 206. As can be seen, there are three relays 250 enablingeight different combinations of the resistors 254 to be switched acrossthe transformer 206 responsive to control signals applied to lines 256 athrough 256 c. Using these various combinations of relays 250, themicroprocessor 104 controls the shape and configuration of the packet ofpulses output by the transformer in a number of fashions which will bediscussed more fully herein below such that the stimulation signal maybe configured in a number of desired modes responsive to user inputs.While only three relays 250 are described with respect to the presentembodiment, any number of relays 250 may be used.

FIG. 2 a illustrates the level translator circuit 270 for generating thetransformer charging signal on line 202. The transformer charging signalis generated by the level translator 270 responsive to control inputs304 and 306 applied to first and second inputs of a NAND gate 274. Theoutput of the NAND gate 274 is provided to three separate inputs of thelevel translator 270. A resistor 276 is connected between the input ofNAND gate 274 connected to control input 304 and ground. An audiospeaker 272 is connected to receive an audio signal from the leveltranslator circuit 270 on line 278 responsive to a control input 308from the microcontroller 104.

Referring now to FIGS. 3 a-3 b, there is illustrated the microprocessor104 for controlling the biofeedback electronic stimulation devicedescribed herein. The microprocessor 104 provides three control outputs256 for controlling the transformer shunt relays 250 describedpreviously. As described herein above, these signals enable the controlof the configuration of the pulse packages generated from thetransformer 206. Control outputs 304, 306 and 308 provide controlsignals to the level translator 270 to control the provision of thetransformer charging signal on output 202 responsive to control signals304 and 306 and to control the audio output to speaker 272 via controloutput 308. An LED circuit 320 receives a number of control outputs 322from the microprocessor 104 to provide various visual indicators to theuser of the biofeedback electronic stimulation device.

Control input 312 receives an input control signal from the detectormodule 132 as described in FIG. 4. The detector module 132 isresponsible for determining the number of zero crossings for pulsesignals generated within signal packets provided by the transformer 206.The input 404 of the detector module 132 is connected to node 226 on oneside of the transformer 206 through capacitor 296 and resistor 298. Theinput 404 is connected to node 406 of the detector 132. A resistor 408is connected between node 406 and system power. A second resistor 410 isconnected between node 406 and system ground. A capacitor 412 is inparallel with resistor 410 between node 406 and ground. A first input ofNAND gate 414 is connected to node 406. The second input of NAND gate414 is connected to system power. The output of NAND gate 414 isconnected to a first input of NAND gate 416. The second input of NANDgate 416 is connected to system power. The output of NAND gate 416 isconnected to control input 312 from the microprocessor 104. A resistor418 is connected between the input of NAND gate 414 connected to node406 and to the output of NAND gate 416. Control inputs 314 and 316 areconnected to a battery sensor circuit.

The processor may use the control signals to control a number ofprocesses within the device. The processor may control the amount ofdamping applied to each pulse. The processor may also control thestimulation pulse applied by the pulse generator to the transformer andthe power or pulse width of the stimulation pulse. Control signals mayalso be generated responsive to the analysis of patterns in a responsesignal from the body and altered in real time. The altered controlsignals may generate a pulse that drives the response from the body to adesired outcome. The analysis may also be communicated to the user or adata collection apparatus along with any derived information.

The generation of the control signals by the microprocessor 104 is morefully described with respect to the flow diagram illustrated in FIG. 5.Initially, at step 502, the microprocessor 104 determines the selectedmode of operation of the biofeedback electronic stimulation deviceresponsive to inputs received from the treatment mode selection switch124 and the power level selection switch 120. From the selected mode andpower level, the microprocessor 104 determines the appropriate controlsignals to be applied to the relays 250 of the damping circuitry 125 andapplies these control signals at step 504. The microprocessor 104 alsodetermines and applies at step 506 the appropriate control signals 125to charge the transformer 206 via the level translator 270. This isaccomplished by applying the appropriate control signals at step 506 tothe level translator circuit 270. The charging signal is continuouslyapplied to the transformer 206 at step 506 until inquiry step 508determines a release point has been received responsive to the appliedcontrol signal from the microprocessor 104.

Once inquiry step 508 determines to release the charging signal, themicroprocessor 104 modifies the control signals applied to thetransformer shunt at step 509 to modify the stimulation signal asdesired. In some embodiments, the control signals applied to thetransformer shunt may remain constant and the control signals will notbe modified at step 509. The microprocessor 104 next monitors thefeedback provided from the electrodes 112 that are providing theelectronic stimulation signal to the body of a user. The specifics ofthe feedback detection will be more fully discussed with respect to FIG.6. Inquiry step 512 determines if the feedback received by themicroprocessor 104 has remained constant for a selected period of time.If not, the microprocessor 104 continues to detect the feedback at step510. Once inquiry step 512 determines that the feedback is constant fora selected period of time, some type of notification is provided at step514 to the user of the biofeedback electronic stimulation device. Thisnotification may take the form of an audio indicator, such as a beepplayed through the speaker 272 or some type of visual indicator throughone of the LEDs or LCD displays 128. The microprocessor 104 thenmonitors for a shut down indication by the user powering off the deviceat inquiry step 516. Inquiry step 516 continues to monitor for some typeof shut down signal until it is received. Upon receipt of a shut downsignal, the microprocessor 104 turns off the device at step 518.

Referring now to FIG. 6, there is illustrated the manner in which themicroprocessor 104 monitors the feedback from the electrodes 112 whichare applying the electronic stimulation signal to an individual's bodyand detecting feedback from the body. The feedback determined by themicroprocessor 104 comprises a determination of the time between zerocrossings of the electronic stimulation signal. The time between thezero crossings of the pulses will alter based upon the resistanceprovided by the body to which the device has been attached. As theresistance in a person's body decreases, the time between zero crossingsof the pulses of a packet will alter. Once the resistance is steady, thetime between zero crossings of the pulses will remain constant and thetreatment regimen may be stopped.

Once the time between the zero crossings of pulses is determined at step602, this time value is stored within a memory associated with themicroprocessor 104 at step 604. Inquiry step 606 determines if a countvalue is equal to a predetermined value that is used for averaging anumber of time values. If not, control passes back to step 602. Once theappropriate number of time values have been stored and count is equal tothe preselected value at inquiry step 606, the average time between thezero crossings of pulses may be determined at step 608. This value maybe compared with a previously determined value at inquiry step 610 todetermine if the determined average time value is constant. If thedetermined average time value is not constant, count is reset to zero atstep 612 and control passes back to step 602. If it is determined thatthe stored time value is constant with a previously stored time value,inquiry step 614 determines if the successive number of average timevalues have been constant for a selected period Y. If not, count isreset to zero and control returns to step 602. Once the average timevalues have been constant for a selected period of time as determined atinquiry step 614, an indicator is generated to the user indicating thedevice may be shut down at step 616. In an alternative embodiment, theindicator could cause the device to automatically shut down rather thanwaiting for a user provided shut down signal.

Referring now to FIG. 7, the control values provided to the transformershunt circuitry and to the level translator for the generation of thetransformer charging signal may be used to configure packets 702 ofpulses 704 which are transmitted in an electronic stimulation signal706. Using the control signals, the packets 702 of pulses 704 arecontrolled in a number of manners. In one embodiment, a time t1 betweena first packet 702 a and a second packet 702 b may be controlled usingthe control signals applied to the level translator circuit 270. Thetime t1 may be varied between adjacent packets or held constant. Themicroprocessor 104 may also control the number of pulses 710 locatedwithin a particular packet 702. The number of pulses 710 may be randomlyvaried between packets, gradually increased/decreased between packets ormaintained constant. The size of the packet 702 may be extended orreduced by altering the number of pulses 704 within a packet 702 throughuse of the applied control signals to the pulse generation circuitry126. The pulses may be varied from any number from 1-n. Within thestimulation signal the size of packets 702 may be varied or constant.

The microprocessor 104 may also control the time t2 between adjacentpulses 704 of a packet 702. This would be an alternative way forincreasing or decreasing the size of a particular packet 702 by alteringthe time t2 between pulses 204 rather than changing the number of pulsesper packet 710 as described previously. The time t2 may also be variedin any number of desired fashions. The time t2 between pulses may alsobe controlled using the control signals to the pulse generationcircuitry 126. Additionally, the pulses 704 may be damped such that theamplitude 714 may be increased or decreased to change the magnitude ofthe pulses 704 provided within the electronic stimulation signal 706.The amplitude 714 is also controlled through the damping circuitry 125and may be done with a combination of the relays 250 in the dampingcircuitry 125.

Referring now to FIGS. 8 a through 8 d, there are illustrated a numberof pulse waveforms that illustrate the variety of outputs that may beachieved from the biofeedback electronic stimulation device describedherein above. FIG. 8 a illustrates a first pulse wherein the chargingsignal has been applied for a medium amount of time and released fromapplication to the transformer at point 802. The output of thetransformer begins the fly back oscillation mode creating theoscillations in the positive and negative directions with a steadilydecreasing magnitude for the oscillation. The time period that thecharging signal is applied between 804 and 802 controls the amplitude ofthe modulations of the output. By varying the release point 802, theamplitude of the output pulse may be increased or decreased. A situationwherein the amplitude of the output pulse is decreased is illustrated inFIG. 8 b. In this figure, the charging time is held between points 804and point 805. Due to the shorter magnitude of the application of thecharging signal, the amplitude of the oscillation of the output signalbetween 806 and 808 is decreased. Referring now to FIG. 8 c, there isillustrated a situation wherein the charging signal is applied betweenpoints 804 and 810 for a longer period of time, causing the amplitude ofthe output pulse to increase.

In addition to controlling the amplitude of the output by controllingthe release point of the charging signal to the transformer, the dampingcircuit may be used to control the output pulse in the mannerillustrated in FIG. 8 d. In this case, the charging signal is appliedbetween points 804 and 812. In this case, the output signal generates asingle oscillation 814 in the negative direction that then approacheszero rather than oscillating in the positive direction. This may beachieved by applying the appropriate load across the output of thetransformer using the damping circuitry 125.

Therefore, using the above-described device, a user may strategicallyapply an electronic stimulation signal to specific parts of their bodyand by the use of mode selection buttons, may control the configurationof the packets of pulses applied to their body. The pulses may beadjusted in any of the fashions discussed herein above.

It will be appreciated by those skilled in the art having the benefit ofthis disclosure that this invention provides an electronic stimulationdevice for providing healing signals to a person's body. It should beunderstood that the drawings and detailed description herein are to beregarded in an illustrative rather than a restrictive manner, and arenot intended to limit the invention to the particular forms and examplesdisclosed. On the contrary, the invention includes any furthermodifications, changes, rearrangements, substitutions, alternatives,design choices, and embodiments apparent to those of ordinary skill inthe art, without departing from the spirit and scope of this invention,as defined by the following claims. Thus, it is intended that thefollowing claims be interpreted to embrace all such furthermodifications, changes, rearrangements, substitutions, alternatives,design choices, and embodiments.

1. A biofeedback electronic stimulation device, comprising: a userinterface for providing at least one input signal; a processor forgenerating a first control signal and a plurality of second controlsignals responsive to the at least one input signal; a pulse generatorcircuit for generating a charge current responsive to the first controlsignal; a transformer for generating a stimulation signal includingpackets of at least one pulse responsive to the charge current; dampingcircuitry for configuring the at least one pulse in the packets to aselected one of a plurality of configurations responsive to theplurality of second control signals; output electrodes for applying thestimulation signal to a user; detector circuitry for detecting zerocrossings of the at least one pulse in the packet of the stimulationsignal; an audio indicator for providing an audio indication to ceaseapplication of the stimulation signal responsive to a third controlsignal from the processor; a visual indicator for providing a visualindication of at least one mode of operation of the device responsive tothe at least one input signal; wherein the processor further causesgeneration of an indicator responsive to the detected zero crossings;and wherein the processor further configures a spacing between thepackets of the stimulation signal, a number of pulses in the packets ofthe stimulation signal, a spacing between the pulses in the packets ofthe stimulation signal, a damping of the pulses in the packets of thestimulation signal.
 2. The biofeedback electronic stimulation device ofclaim 1, wherein the spacing between packets of the stimulation signalmay be varied between each packet.
 3. The biofeedback electronicstimulation device of claim 1, wherein the number of pulses in thepackets of the stimulation signal vary between the packets.
 4. Thebiofeedback electronic stimulation device of claim 1, wherein the spacesbetween pulses may be altered between packets of the stimulation signal.5. The biofeedback electronic stimulation device of claim 1, wherein themicroprocessor measures an average time between zero crossingsresponsive to occurrence of a selected number of detected zero crossingsand generates the indicator when the average time between zero crossingsis equal for a predetermined number of times.
 6. The biofeedbackelectronic stimulation device of claim 1, further including a universalserial bus connector providing an external connection to the processor.7. The biofeedback electronic stimulation device of claim 1, wherein theat least one input signal selects one of a plurality of modes ofoperation, each mode of the plurality of modes of operation having aselected first control signal and a selected plurality of second controlsignals associated therewith.
 8. The biofeedback electronic stimulationdevice of claim 1, wherein the processor further controls an amount ofdamping applied to each pulse.
 9. The biofeedback electronic stimulationdevice of claim 1, wherein the processor further varies a power ofstimulation pulse applied to the transformer by the pulse generatorcircuit.
 10. The biofeedback electronic stimulation device of claim 1,wherein the controller analyzes patterns in response signals receivedfrom a body of a user and based on detected patterns alters the controlsignals in real time.
 11. The biofeedback electronic stimulation deviceof claim 9 wherein the analysis of the body response signals may be usedto alter the controlling parameters of the pulse such that the responseof the body is driven toward a desired outcome.
 12. The biofeedbackelectronic stimulation device of claim 11 wherein the analysis of thebody response signals further may cause additional derived informationto be communicated to the user or to a data collection apparatus.